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Kaiser Permanente-Sunnyside Medical Center FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection NAI · Mar 11, 2025
No warning letters matched by name

Inspections 8

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Kaiser Permanente-Sunnyside Medical Center has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Kaiser Permanente-Sunnyside Medical Center" is on file.

What these totals cover: FDA records filed under the name "Kaiser Permanente-Sunnyside Medical Center".

Latest inspection: Mar 11, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	8	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Kaiser Permanente-Sunnyside Medical Center's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Kaiser Permanente-Sunnyside Medical Center: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	1	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	1	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

8 inspections from May 14, 2009 to Mar 11, 2025.

Date	Site	Product	Classification	FEI
Mar 11, 2025	Clackamas, OR	Biologics	No Action Indicated (NAI)	3076999
Dec 7, 2021	Clackamas, OR	Biologics	No Action Indicated (NAI)	3076999
Jul 31, 2018	Clackamas, OR	Biologics	No Action Indicated (NAI)	3076999
Nov 2, 2016	Clackamas, OR	Biologics	Voluntary Action Indicated (VAI)	3076999
Dec 4, 2014	Clackamas, OR	Biologics	Voluntary Action Indicated (VAI)	3076999
Feb 13, 2013	Clackamas, OR	Biologics	Voluntary Action Indicated (VAI)	3076999
Mar 14, 2011	Clackamas, OR	Biologics	Voluntary Action Indicated (VAI)	3076999
May 14, 2009	Clackamas, OR	Biologics	No Action Indicated (NAI)	3076999

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3076999	Clackamas, OR	8	Mar 11, 2025

Kaiser Permanente-Sunnyside Medical Center and the FDA: common questions

Has Kaiser Permanente-Sunnyside Medical Center received an FDA warning letter?

No FDA warning letter addressed to the name "Kaiser Permanente-Sunnyside Medical Center" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Kaiser Permanente-Sunnyside Medical Center received an FDA Form 483?

FDA has not published a Form 483 for "Kaiser Permanente-Sunnyside Medical Center" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Kaiser Permanente-Sunnyside Medical Center?

The most recent FDA inspection on file ended Mar 11, 2025 at Clackamas, OR and was classified NAI. FDA has 8 inspections of Kaiser Permanente-Sunnyside Medical Center on file.

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